Zirconia Crowns for Tooth Decay

Overseen By Jayakumar Jayaraman, MDS, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Bruxism, Special health needs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of zirconia crowns (tooth caps) to restore front baby teeth and prevent further decay and infection. It compares crowns with grooves for extra grip to those without grooves to determine which is more effective for children's dental health. The trial seeks children aged 2 to 6 with early childhood cavities, particularly those requiring dental treatment under general anesthesia. As an unphased trial, it offers participants a unique opportunity to contribute to advancements in pediatric dental care.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that these crowns are safe for dental restoration?

Research has shown that zirconia crowns for baby teeth are generally safe and well-tolerated. Known for their strength and aesthetic appeal, these crowns have demonstrated effectiveness. In one study, 18% of crowns caused wear on the opposing tooth, occurring slightly more often in crowns without grooves than those with grooves. However, zirconia crowns also promote better gum health and resist breaking, indicating overall safety.

For crowns with grooves, similar safety outcomes have been observed. Studies comparing crowns with and without grooves reveal that both types effectively restore teeth. The grooves do not significantly impact safety, with only minor differences noted.

Overall, zirconia crowns, whether grooved or not, provide a safe option for treating cavities in baby teeth. Their strength and natural appearance make them a popular choice for dental restoration. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about zirconia crowns for tooth decay because they offer a durable and aesthetically pleasing alternative to traditional stainless steel crowns. Unlike metal crowns, zirconia crowns blend seamlessly with natural teeth due to their tooth-colored appearance, making them a preferred choice for visible front teeth. Additionally, the trial is exploring crowns with and without retention grooves, which could affect how well they stay in place and adapt to individual needs. This variability in design might allow dentists to tailor treatments more precisely, enhancing overall dental health and patient satisfaction.

What evidence suggests that this trial's crowns could be effective for tooth decay?

This trial will compare two types of zirconia crowns for repairing baby teeth: zirconia-based primary anterior crowns without retention grooves and those with retention grooves. Studies have shown that both types effectively repair baby teeth. These crowns securely adhere to teeth and are very strong. Research indicates that zirconia crowns also promote healthy gums and teeth, which is crucial for preventing further decay. Some studies found slight wear on the teeth opposite the crown, but this was not a significant issue. Overall, both types of zirconia crowns are strong options for repairing teeth and preventing future dental problems in children. ^{1 2 3 6 7}

Who Is on the Research Team?

Jayakumar Jayaraman, MDS, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for individuals with tooth decay who need crowns on their front teeth. The study is testing two types of zirconia-based crowns: one with retention grooves and one without. Specific eligibility details are not provided, so it's best to contact the researchers for more information.

Inclusion Criteria

I have been treated under general anesthesia.

My child is healthy and between 2 to 6 years old.

I have tooth decay that started in early childhood.

Exclusion Criteria

I have worn down or missing opposing teeth.

Teeth that have been subjected to trauma

My teeth are about to fall out.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zirconia-based primary anterior crowns with or without retention grooves

3 months

1 visit (in-person)

Follow-up

Participants are monitored for clinical and radiographic outcomes, as well as parental and child satisfaction

36 months

Multiple visits at 3, 6, 12, 24, and 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Zirconia-based primary anterior crowns without retention grooves
• Zirconia-based primary anterior crowns with retention grooves

Trial Overview The effectiveness of two different designs of zirconia-based crowns for front teeth is being compared. One design includes retention grooves that may help hold the crown in place, while the other does not have these grooves.

How Is the Trial Designed?

Group I: Zirconia-based primary anterior crowns without retention grooves Experimental Treatment 1 Intervention

Participants will receive zirconia-based primary anterior crowns without retention grooves

Group II: Zirconia-based primary anterior crowns with retention grooves Experimental Treatment 1 Intervention

Participants will receive zirconia-based primary anterior crowns with retention grooves

Zirconia-based primary anterior crowns without retention grooves is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Zirconia crowns for:

• Restoration of primary anterior teeth
• Prevention of further caries and infection

Approved in United States as Zirconia crowns for:

• Restoration of primary anterior teeth
• Prevention of further caries and infection

Approved in Canada as Zirconia crowns for:

• Restoration of primary anterior teeth
• Prevention of further caries and infection

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Published Research Related to This Trial

Aesthetic zirconia crowns (ZCs) show adequate properties for restoring decayed primary teeth, including good mechanical resistance and a natural appearance, but there is limited clinical evidence supporting their use compared to stainless steel crowns (SSCs).

Despite the aesthetic advantages of ZCs, stainless steel crowns remain the gold standard for primary teeth restoration, highlighting the need for further research to evaluate the efficacy of ZCs in pediatric dentistry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zirconia vs. stainless steel pediatric crowns: a literature review. Ludovichetti, FS., Stellini, E., Signoriello, AG., et al.[2021]

A zirconia crown was successfully used to restore a primary molar in an 8-year-old boy, demonstrating effective long-term functionality and aesthetics over a follow-up period of 29 months.

The study highlights the importance of proper implementation and maintenance protocols for zirconia crowns, showing that they can maintain gingival health and minimize wear on opposing teeth while providing a natural appearance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twenty-nine-month follow-up of a paediatric zirconia dental crown. Lopez Cazaux, S., Hyon, I., Prud'homme, T., et al.[2020]

Zirconia crowns provide an effective and aesthetically pleasing solution for restoring extensively decayed primary maxillary anterior teeth in young children, as demonstrated in a case study over a 30-month period.

The crowns showed good retention and functional results after endodontic treatment, making them a practical choice for pediatric dentists dealing with significant tooth structure loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zirconia crowns for rehabilitation of decayed primary incisors: an esthetic alternative. Ashima, G., Sarabjot, KB., Gauba, K., et al.[2022]

Zirconia crowns (ZC) placed on primary maxillary anterior teeth showed good marginal integrity in 82.4% of cases and satisfactory aesthetics, making them a viable treatment option for carious teeth in children.

The study found that crowns placed under general anesthesia had better marginal integrity and periodontal health compared to those placed under sedation, and pulpotomized teeth had poorer color matching with adjacent teeth, indicating the importance of treatment conditions on outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zirconia crown performance in primary maxillary anterior teeth: a retrospective photographic and radiographic cohort study. Yanover, L., Tickotsky, N., Waggoner, W., et al.[2022]

Zirconia crowns are more effective than other types of crowns for restoring primary teeth in children, showing better results in terms of gingival health, aesthetics, and resistance to fractures based on a systematic review of 24 relevant studies.

However, the use of zirconia crowns may lead to increased tooth preparation and wear on opposing teeth, indicating a need for careful consideration in their application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Restorative Full Crowns Made with Zirconia in Children: A Systematic Review. Ajayakumar, LP., Chowdhary, N., Reddy, VR., et al.[2022]

In a study involving 18 participants and 20 zirconia-based anterior maxillary crowns, all crowns showed excellent durability with no fractures or chipping after an average follow-up of 58.7 months.

Participants reported high satisfaction with their crowns (average score of 9.8 out of 10), and there were no instances of proximal caries or periapical pathoses detected over the 5-year period, indicating strong clinical performance and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective cohort clinical study assessing the 5-year survival and success of anterior maxillary zirconia-based crowns with customized zirconia copings. Dogan, S., Raigrodski, AJ., Zhang, H., et al.[2018]

Zirconia crowns are a highly satisfactory treatment option for decayed primary anterior teeth, with both parents and children reporting high levels of satisfaction based on a review of nine studies.

The studies indicate that zirconia crowns provide clinically acceptable restorations for maxillary primary incisors, but future research should involve larger sample sizes and longer follow-up periods to further validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Clinical, Child, and Parental Satisfaction with Zirconia Crowns in Maxillary Primary Incisors: A Systematic Review. Hamrah, MH., Mokhtari, S., Hosseini, Z., et al.[2022]

In a study involving 20 children aged three to five, parents showed a preference for prefabricated primary anterior zirconia crowns over strip crowns, particularly valuing the longevity of the zirconia crowns.

Both types of crowns received positive feedback, but parents noted a significant correlation between their overall satisfaction and the longevity and color of the restorations, with zirconia crowns performing better in terms of longevity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Parental Satisfaction with Various Aesthetic Crowns Among Children of Various Age Groups: An Original Research. Verma, RK., Srilatha, V., Patel, S., et al.[2023]

Citations

1. scholarscompass.vcu.edu scholarscompass.vcu.edu/etd/8092/

Effectiveness of zirconia-based primary anterior crowns with ... This clinical trial aimed to evaluate the effectiveness of zirconia-based primary anterior crowns with and without retention grooves in children aged 2-6 years.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8910015/

Zirconia Crowns for Primary Teeth: A Systematic Review ... The included studies reported that zirconia crowns for primary teeth were associated with better gingival and periodontal health, good retention, high fracture ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05121584

Evaluation of Two Different Types of Zirconia Crowns Used ... Deep carious primary upper canines; The tooth need pulpal treatment; The tooth need a crown restoration; The tooth not submerged; The tooth is not mobile.

4. ctv.veeva.com ctv.veeva.com/study/zirconia-based-primary-anterior-crowns-with-retention-grooves-versus-without-retention-grooves

Zirconia-based Primary Anterior Crowns With Retention ... The purpose of this research study is to test the effectiveness of two different crowns/caps on teeth for restoration of primary anterior ...

5. journals.lww.com journals.lww.com/tdoj/fulltext/2025/01000/evaluation_of_two_different_types_of_zirconia.19.aspx

Evaluation of two different types of zirconia crowns used... Based on our results, we conclude that both zirconia crowns can be used as an effective full-coverage restoration for the primary canines, retentive, had ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12579444/

Comparative Evaluation of Esthetic Zirconia Crowns in Children Zirconia crowns provide a clinically superior option for rehabilitation of primary teeth, combining esthetic excellence with functional ...

7. withpower.com withpower.com/trial/phase-dental-decay-4-2024-7eb7e

Zirconia Crowns for Tooth Decay · Info for Participants A prospective cohort study assessed the 5-year survival and success of anterior maxillary zirconia-based crowns, although it noted limited studies in this area.